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Brief Summary:
The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.
Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.
The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromodulation experimental group | Experimental | The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks. The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes. |
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| Neuromodulation sham group | Sham Comparator | The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks. The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.The treatment will be applied with a placebo device that does not emit microcurrent but that has the same function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation group | Other | During the 12 sessions of which the treatment consists in applying 60 minutes of microcurrent in low intensity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health), orientated from the left (worst) to the right (best) | Change from Baseline at one month. |
| Measure | Description | Time Frame |
|---|---|---|
| DN4 scale | It is a clinician-administered questionnaire consisting of 10 items.Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. These components refer to how the pain feels to the patient Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia).The 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Pecos-Martin, PhD | Alcala University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Investigación Fisioterapia y Dolor | Alcalá de Henares | Madrid | 28805 | Spain |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Neuromodulation sham group | Other | During the 12 sessions of which the treatment consists in applying 60 minutes of sham microcurrent in low intensity. |
|
| Change from Baseline at one month. |
| Pittsburg Sleep Quality Index score | IThe Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality.The scores range from 0 to 21 and the authors suggest that a score >5 be considered as a significant sleep disturbance. | Change from Baseline at one month. |
| Hospital Anxiety and Depression Scale (HAND) | The HADS is a questionnaire widely used to evaluate anxiety and depression. A 14-item questionnaire to rate patient´s depression and anxiety. Each item has a 0-3 score indicating worse results with higher score | Change from Baseline at one month |
| Quality of life SF12 | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. A higher score is better outcome. | Change from Baseline at one month. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |